Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies.

NCT04788875 | Unknown

• 1 other identifier: SBT-CML
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the attempt to gain quick and complete access to the abdominal regions with the least damage to the nerves and the vascular structures, surgeons use the median laparotomy more frequently. However, postoperative complications such as incisional hernia continue to be the known leading complications after median laparotomy. The reported cases to range from 2 to 20%. Higher cases have also been reported with up to 35% in the absence and aortic patients. Recent statistics have showed that small tissue bites prevent incisional hernia can occur in the aponeurosis. This technique is more effective than the commonly used process, which involves large edges of mass closure. In this study investigators aim to compare small bites sutures in closure of laparotomy incision and standardized large bites sutures, and its affect in reducing the incidence of incisional hernia postoperative along with the surgical site infection. the investigators hypothesize that the small bites technique will result in a significant reduction of the incidence of incisional hernia and optimize the surgical site infection in major surgeries which may lead to a reduced morbidity and a better quality of life for patients and a significant reduction of costs.

Conditions

Incision, Surgical; Suture, Complication; Incisional Hernia

Outcome Measures

Primary Outcomes (16)

• Incidence of Incisional Hernia postoperative

  Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.

  Follow up on 6 month postoperative.

• Incidence of Incisional Hernia postoperative

  Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.

  Follow up on 1 year postoperative.

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 1 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 2 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 3 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 4 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 5 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 6 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 7 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 8 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 9 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 10 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 11 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 12 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 13 postoperative

• Assessment of pain severity postoperative by pain scale

  Assessment of pain scale post operative, lower score mean a better outcome.

  Day 14 postoperative

Secondary Outcomes (19)

• Assessment of early mobilisation

  Postoperative period, assessment in day1.

• Assessment of early mobilisation

  Postoperative period, assessment in day2.

• Assessment of early mobilisation

  Postoperative period, assessment in day3.

• Retain to work (how many days between surgery and patient back to his work)

  up to 6 weeks, postoperative period from discharge until day patient back to work.

• Surgical site infection of the wound postoperative

  day 1 postoprtaive.

Study Arms (2)

Small Bite Technique Group

ACTIVE COMPARATOR

closure of laparotomy by small bites technique using PDS 2.0

Procedure: Small bite suturing Technique

Standardised Large Bites Technique Group

OTHER

usual practice closure of laparotomy by standardised large bites technique using PDS 2.0

Procedure: Standardised Large Bites Technique

Interventions

Small bite suturing Technique PROCEDURE

Small bite suturing technique with PDS 2.0

Small Bite Technique Group

Standardised Large Bites Technique PROCEDURE

Standardised large bite suturing technique with PDS 2.0

Standardised Large Bites Technique Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laparotomy through a midline incision
• Age more than 18
• BMI \< 40

You may not qualify if:

• Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision.
• Abdominal surgery through a midline incision within the last three months.
• Pregnancy.
• Patient on steroids and with genetic anomalies.
• Malignancy patients, next exposed to radiation therapy.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

MeSH Terms

Conditions

Surgical Wound; Incisional Hernia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Nasser M Amer

  Imam Abdulrahman Bin Faisal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasser M Amer

CONTACT

00966 53 865 9290; nmamer@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded. (patients and research recruiter)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of General Surgery in Imam Abdulrahman bin Faisal University

Model Details: 2 Arms Arm1) Closure of laparotomy by small bites technique using PDS 2.0 Arm2) Closure of laparotomy by standardised large bites technique This research will include all patients who will had laparotomy through a midline incision according to our inclusion criteria, they will be randomised using computer generated numbers by using (Random.org), to either closure by small bites technique using PDS 2.0 or standardised large bites technique.

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: March 9, 2021
• Study Start: December 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 8, 2021

Record last verified: 2021-10